Intraocular shunt placement

ABSTRACT

Methods are provided for using an intraocular shunt deployment device to deploy an intraocular shunt from the device and into an eye.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/946,653, filed on Nov. 15, 2010, the entirety of which isincorporated herein by reference.

BACKGROUND

1. Field of the Invention

The invention generally relates to methods for using an intraocularshunt deployment device to deploy an intraocular shunt from the deviceand into an eye.

2. Description of the Related Art

Glaucoma is a disease of the eye that affects millions of people.Glaucoma is associated with an increase in intraocular pressureresulting either from a failure of a drainage system of an eye toadequately remove aqueous humor from an anterior chamber of the eye oroverproduction of aqueous humor by a ciliary body in the eye. Build-upof aqueous humor and resulting intraocular pressure may result inirreversible damage to the optic nerve and the retina, which may lead toirreversible retinal damage and blindness.

Glaucoma may be treated by surgical intervention that involves placing ashunt in the eye to result in production of fluid flow pathways betweenthe anterior chamber and various structures of the eye involved inaqueous humor drainage (e.g., Schlemm's canal, the sclera, or thesubconjunctival space). Such fluid flow pathways allow for aqueous humorto exit the anterior chamber. Generally, the surgical intervention toimplant the shunt involves inserting into the eye a deployment devicethat holds an intraocular shunt, and deploying the shunt within the eye.A deployment device holding the shunt enters the eye through a cornea(ab interno approach), and is advanced across the anterior chamber. Thedeployment device is advanced through the sclera until a distal portionof the device is in proximity to a drainage structure of the eye. Theshunt is then deployed from the deployment device, producing a conduitbetween the anterior chamber and various structures of the eye involvedin aqueous humor drainage (e.g., Schlemm's canal, the sclera, or thesubconjunctival space). See for example, Prywes (U.S. Pat. No.6,007,511).

A problem associated with such surgical interventions is ensuring thatplacement of the shunt does not change during deployment of the shuntfrom the deployment device. Deployment devices that are used to placethe shunt in the eye generally rely on multiple moving components inorder to deploy the shunt. Movement of the components of the deploymentdevice shifts the position of the deployment device within the eyeduring the deployment process, and thus shifts the position of the shuntas it is being deployed. Such movement leads to improper placement ofthe shunt within the eye.

SUMMARY

The invention generally relates to deployment devices that are designedto minimize movement of the device during deployment of an intraocularshunt from the device, thereby ensuring proper placement of the shuntwithin the eye.

In certain aspects, deployment devices of the invention include ahousing, a deployment mechanism at least partially disposed within thehousing, and a hollow shaft coupled to the deployment mechanism, inwhich the shaft is configured to hold an intraocular shunt. With suchdevices, rotation of the deployment mechanism results in deployment ofthe shunt. Such rotational movement is translated into axial movementfor deploying the shunt from the device. By utilizing rotationalmovement for the deployment mechanism, axial movement of the deploymentdevice is minimized, ensuring proper placement of the shunt within theeye.

Other aspects of the invention provide devices for deploying anintraocular shunt including a housing, a deployment mechanism at leastpartially disposed within the housing, in which the deployment mechanismincludes a two stage system, and a hollow shaft coupled to thedeployment mechanism, in which the shaft is configured to hold anintraocular shunt.

Another aspect of the invention includes devices for deploying anintraocular shunt including a housing, a deployment mechanism at leastpartially disposed within the housing, and a hollow shaft coupled insidethe housing to the deployment mechanism, wherein the shaft is configuredto hold an intraocular shunt, in which the device includes an insertionconfiguration and a deployment configuration and the deploymentconfiguration includes a proximal portion of the shaft being at leastpartially retracted to within the housing. In certain embodiments, theinsertion configuration includes a distal portion of the shaft beingdisposed within the housing and a proximal portion of the shaftextending beyond the housing.

In certain embodiments, the shaft is configured to at least partiallyretract to within the housing. However, it will be appreciated that theshaft may fully retract to within the housing.

In certain embodiments, the device further includes the intraocularshunt. The shunt may be completely disposed within the hollow shaft ofthe device. Alternatively, the shunt is partially disposed within thehollow shaft of the device.

The deployment mechanism may include a two stage system. In suchembodiments, the first stage is a pusher component and the second stageis a retraction component. In this embodiment, rotation of thedeployment mechanism sequentially engages the pusher component and thenthe retraction component. The pusher component pushes the shunt topartially deploy the shunt from within the shaft, and the retractioncomponent retracts the shaft from around the shunt, thereby deployingthe shunt. In certain embodiments, the deployment mechanism mayadditionally include at least one member that limits axial movement ofthe shaft.

The hollow shaft of the deployment device may include a beveled distalend. An exemplary hollow shaft is a needle. Devices of the invention maybe completely automated, partially automated, or completely manual.Devices of the invention may be connected to larger robotic systems ormay be used as stand-alone handheld deployment devices. In particularembodiments, the device is a handheld device.

Devices of the invention may include an indicator that provides feedbackto an operator as to the state of the deployment mechanism. Theindicator may be any type of indicator known in the art, for example avisual indicator, an audio indicator, or a tactile indicator. In certainembodiments, the indicator is a visual indicator.

Aspects of the invention also include methods for deploying anintraocular shunt within an eye. These methods involve using devicesdescribed herein to deploy an intraocular shunt from the device withinthe eye. Generally, deploying the shunt results in a flow path from ananterior chamber of the eye to an area of lower pressure. Exemplaryareas of lower pressure include intra-Tenon's space, the subconjunctivalspace, the episcleral vein, the suprachoroidal space, and Schlemm'scanal. In certain embodiments, the area of lower pressure is thesubarachnoid space.

Any of a variety of methods known in the art may be used to insertdevices of the invention into an eye. In certain embodiments, devices ofthe invention may be inserted into the eye using an ab externo approach(entering through the conjunctiva) or an ab interno approach (enteringthrough the cornea).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic showing an embodiment of a shunt deployment deviceaccording to the invention.

FIG. 2 shows an exploded view of the device shown in FIG. 1.

FIGS. 3A-3D are schematics showing different enlarged views of thedeployment mechanism of the deployment device.

FIGS. 4A-4C are schematics showing interaction of the deploymentmechanism with a portion of the housing of the deployment device.

FIG. 5 shows a cross sectional view of the deployment mechanism of thedeployment device.

FIGS. 6A-6B show schematics of the deployment mechanism in apre-deployment configuration.

FIG. 6C shows an enlarged view of the distal portion of the deploymentdevice of FIG. 6A. This figure shows an intraocular shunt loaded withina hollow shaft of the deployment device.

FIGS. 7A-7B show schematics of the deployment mechanism at the end ofthe first stage of deployment of the shunt from the deployment device.

FIG. 7C shows an enlarged view of the distal portion of the deploymentdevice of FIG. 7A. This figure shows an intraocular shunt partiallydeployed from within a hollow shaft of the deployment device.

FIG. 8A shows a schematic of the deployment device after deployment ofthe shunt from the device.

FIG. 8B show a schematic of the deployment mechanism at the end of thesecond stage of deployment of the shunt from the deployment device.

FIG. 8C shows an enlarged view of the distal portion of the deploymentdevice after retraction of the shaft with the pusher abutting the shunt.

FIG. 8D shows an enlarged view of the distal portion of the deploymentdevice after deployment of the shunt.

FIGS. 9A-9B show an intraocular shunt deployed within the eye. Aproximal portion of the shunt resides in the anterior chamber and adistal portion of the shunt resides within the intra-Tenon's space. Amiddle portion of the shunt resides in the sclera.

FIGS. 10A-10E show an intraocular shunt being deployed within the eye,according to another embodiment.

FIG. 11 depicts a schematic of an exemplary intraocular shunt.

DETAILED DESCRIPTION

Reference is now made to FIG. 1, which shows an embodiment of a shuntdeployment device 100 according to the invention. While FIG. 1 shows ahandheld manually operated shunt deployment device, it will beappreciated that devices of the invention may be coupled with roboticsystems and may be completely or partially automated. As shown in FIG.1, deployment device 100 includes a generally cylindrical body orhousing 101; however, the body shape of housing 101 could be other thancylindrical. Housing 101 may have an ergonomical shape, allowing forcomfortable grasping by an operator. Housing 101 is shown with optionalgrooves 102 to allow for easier gripping by a surgeon.

Housing 101 is shown having a larger proximal portion that tapers to adistal portion. The distal portion includes a hollow sleeve 105. Thehollow sleeve 105 is configured for insertion into an eye and to extendinto an anterior chamber of an eye. The hollow sleeve is visible withinan anterior chamber of an eye. The sleeve 105 provides a visual previewfor an operator as to placement of the proximal portion of the shuntwithin the anterior chamber of an eye. Additionally, the sleeve 105provides a visual reference point that may be used by an operator tohold device 100 steady during the shunt deployment process, therebyassuring optimal longitudinal placement of the shunt within the eye.

The sleeve 105 may include an edge 131 at a distal end that providesresistance feedback to an operator upon insertion of the deploymentdevice 100 within an eye 132 of a person during delivery of the shunt115, as shown in FIGS. 10A-10E. Upon advancement of the device 100across an anterior chamber 133 of the eye 132, the hollow sleeve 105will eventually contact the sclera 134, providing resistance feedback toan operator that no further advancement of the device 100 is necessary.The edge 131 of the sleeve 105 prevents the shaft 104 from accidentallybeing pushed too far through the sclera 134. A temporary guard 108 isconfigured to fit around sleeve 105 and extend beyond an end of sleeve105. The guard is used during shipping of the device and protects anoperator from a distal end of a hollow shaft 104 that extends beyond theend of the sleeve 105. The guard is removed prior to use of the device.

Housing 101 is open at its proximal end, such that a portion of adeployment mechanism 103 may extend from the proximal end of the housing101. A distal end of housing 101 is also open such that at least aportion of a hollow shaft 104 may extend through and beyond the distalend of the housing 101. Housing 101 further includes a slot 106 throughwhich an operator, such as a surgeon, using the device 100 may view anindicator 107 on the deployment mechanism 103.

Housing 101 may be made of any material that is suitable for use inmedical devices. For example, housing 101 may be made of a lightweightaluminum or a biocompatible plastic material. Examples of such suitableplastic materials include polycarbonate and other polymeric resins suchas DELRIN and ULTEM. In certain embodiments, housing 101 is made of amaterial that may be autoclaved, and thus allow for housing 101 to bere-usable. Alternatively, device 100 may be sold as a one-time-usedevice, and thus the material of the housing does not need to be amaterial that is autoclavable.

Housing 101 may be made of multiple components that connect together toform the housing. FIG. 2 shows an exploded view of deployment device100. In this figure, housing 101, is shown having three components 101a, 101 b, and 101 c. The components are designed to screw together toform housing 101. FIG. 2 also shows deployment mechanism 103. Thehousing 101 is designed such that deployment mechanism 103 fits withinassembled housing 101. Housing 101 is designed such that components ofdeployment mechanism 103 are movable within housing 101.

FIGS. 3A-3D show different enlarged views of the deployment mechanism103. Deployment mechanism 103 may be made of any material that issuitable for use in medical devices. For example, deployment mechanism103 may be made of a lightweight aluminum or a biocompatible plasticmaterial. Examples of such suitable plastic materials includepolycarbonate and other polymeric resins such as DELRIN and ULTEM. Incertain embodiments, deployment mechanism 103 is made of a material thatmay be autoclaved, and thus allow for deployment mechanism 103 to bere-usable. Alternatively, device 100 may be sold as a one-time-usedevice, and thus the material of the deployment mechanism does not needto be a material that is autoclavable.

Deployment mechanism 103 includes a proximal portion 109 and a distalportion 110. The deployment mechanism 103 is configured such thatproximal portion 109 is movable within distal portion 110. Moreparticularly, proximal portion 109 is capable of partially retracting towithin distal portion 110.

In this embodiment, the proximal portion 109 is shown to taper to aconnection with a hollow shaft 104. This embodiment is illustrated suchthat the connection between the hollow shaft 104 and the proximalportion 109 of the deployment mechanism 103 occurs inside the housing101. In other embodiments, the connection between hollow shaft 104 andthe proximal portion 109 of the deployment mechanism 103 may occuroutside of the housing 101. Hollow shaft 104 may be removable from theproximal portion 109 of the deployment mechanism 103. Alternatively, thehollow shaft 104 may be permanently coupled to the proximal portion 109of the deployment mechanism 103.

Generally, hollow shaft 104 is configured to hold an intraocular shunt115. An exemplary intraocular shunt 115 is shown in FIG. 11. Otherexemplary intraocular shunts are shown in Yu et al. (U.S. PatentApplication No. 2008/0108933). Generally, in one embodiment, intraocularshunts are of a cylindrical shape and have an outside cylindrical walland a hollow interior. The shunt may have an inner diameter ofapproximately 50 μm to approximately 250 μm, an outside diameter ofapproximately 190 μm to approximately 300 μm, and a length ofapproximately 0.5 mm to about 20 mm. Thus, hollow shaft 104 isconfigured to at least hold a shunt of such shape and such dimensions.However, hollow shaft 104 may be configured to hold shunts of differentshapes and different dimensions than those described above, and theinvention encompasses a shaft 104 that may be configured to hold anyshaped or dimensioned intraocular shunt. In particular embodiments, theshaft has an inner diameter of approximately 200 μm to approximately 400μm.

The shaft 104 may be any length. A usable length of the shaft may beanywhere from about 5 mm to about 40 mm, and is 15 mm in certainembodiments. In certain embodiments, the shaft is straight. In otherembodiments, shaft is of a shape other than straight, for example ashaft having a bend along its length or a shaft having an arcuateportion. Exemplary shaped shafts are shown for example in Yu et al.(U.S. Patent Application No. 2008/0108933). In particular embodiments,the shaft includes a bend at a distal portion of the shaft. In otherembodiments, a distal end of the shaft is beveled or is sharpened to apoint.

The shaft 104 may hold the shunt at least partially within the hollowinterior of the shaft 104. In other embodiments, the shunt is heldcompletely within the hollow interior of the shaft 104. Alternatively,the hollow shaft may hold the shunt on an outer surface of the shaft104. In particular embodiments, the shunt is held within the hollowinterior of the shaft 104. In certain embodiments, the hollow shaft is aneedle having a hollow interior. Needles that are configured to hold anintraocular shunt are commercially available from Terumo Medical Corp.(Elkington, Md.).

A distal portion of the deployment mechanism includes optional grooves116 to allow for easier gripping by an operator for easier rotation ofthe deployment mechanism, which will be discussed in more detail below.The distal portion 110 of the deployment mechanism also includes atleast one indicator that provides feedback to an operator as to thestate of the deployment mechanism. The indicator may be any type ofindicator known in the art, for example, a visual indicator, an audioindicator, or a tactile indicator. FIG. 3 shows a deployment mechanismhaving two indicators, a ready indicator 111 and a deployed indicator119. Ready indicator 111 provides feedback to an operator that thedeployment mechanism is in a configuration for deployment of anintraocular shunt from the deployment device 100. The indicator 111 isshown in this embodiment as a green oval having a triangle within theoval. Deployed indicator 119 provides feedback to the operator that thedeployment mechanism has been fully engaged and has deployed the shuntfrom the deployment device 100. The deployed indicator 119 is shown inthis embodiment as a yellow oval having a black square within the oval.The indicators are located on the deployment mechanism such that whenassembled, the indicators 111 and 119 may be seen through slot 106 inhousing 101.

The distal portion 110 includes a stationary portion 110 b and arotating portion 110 a. The distal portion 110 includes a channel 112that runs part of the length of stationary portion 110 b and the entirelength of rotating portion 110 a. The channel 112 is configured tointeract with a protrusion 117 on an interior portion of housingcomponent 101 a (FIGS. 4A and 4B). During assembly, the protrusion 117on housing component 101 a is aligned with channel 112 on the stationaryportion 110 b and rotating portion 110 a of the deployment mechanism103. The distal portion 110 of deployment mechanism 103 is slid withinhousing component 101 a until the protrusion 117 sits within stationaryportion 110 b (FIG. 4C). Assembled, the protrusion 117 interacts withthe stationary portion 110 b of the deployment mechanism 103 andprevents rotation of stationary portion 110 b. In this configuration,rotating portion 110 a is free to rotate within housing component 101 a.

Referring back to FIG. 3, the rotating portion 110 a of distal portion110 of deployment mechanism 103 also includes channels 113 a, 113 b, and113 c. Channel 113 a includes a first portion 113 a 1 that is straightand runs perpendicular to the length of the rotating portion 110 a, anda second portion 113 a 2 that runs diagonally along the length ofrotating portion 110 a, downwardly toward a distal end of the deploymentmechanism 103. Channel 113 b includes a first portion 113 b 1 that runsdiagonally along the length of the rotating portion 110 a, upwardlytoward a proximal end of the deployment mechanism 103, and a secondportion that is straight and runs perpendicular to the length of therotating portion 110 a. The point at which first portion 113 a 1transitions to second portion 113 a 2 along channel 113 a, is the sameas the point at which first portion 113 b 1 transitions to secondportion 113 b 2 along channel 113 b. Channel 113 c is straight and runsperpendicular to the length of the rotating portion 110 a. Within eachof channels 113 a, 113 b, and 113 c, sit members 114 a, 114 b, and 114 crespectively. Members 114 a, 114 b, and 114 c are movable withinchannels 113 a, 113 b, and 113 c. Members 114 a, 114 b, and 114 c alsoact as stoppers that limit movement of rotating portion 110 a, whichthereby limits axial movement of the shaft 104.

FIG. 5 shows a cross-sectional view of deployment mechanism 103. Member114 a is connected to the proximal portion 109 of the deploymentmechanism 103. Movement of member 114 a results in retraction of theproximal portion 109 of the deployment mechanism 103 to within thedistal portion 110 of the deployment mechanism 103. Member 114 b isconnected to a pusher component 118. The pusher component 118 extendsthrough the proximal portion 109 of the deployment mechanism 103 andextends into a portion of hollow shaft 104. The pusher component isinvolved in deployment of a shunt from the hollow shaft 104. Anexemplary pusher component is a plunger. Movement of member 114 bengages pusher 118 and results in pusher 118 advancing within hollowshaft 104.

Reference is now made to FIGS. 6A-8D, which accompany the followingdiscussion regarding deployment of a shunt 115 from deployment device100. FIG. 6A shows deployment device 100 is a pre-deploymentconfiguration. In this configuration, shunt 115 is loaded within hollowshaft 104 (FIG. 6C). As shown in FIG. 6C, shunt 115 is only partiallywithin shaft 104, such that a portion of the shunt is exposed. However,the shunt 115 does not extend beyond the end of the shaft 104. In otherembodiments, the shunt 115 is completely disposed within hollow shaft104. The shunt 115 is loaded into hollow shaft 104 such that the shuntabuts pusher component 118 within hollow shaft 104. A distal end ofshaft 104 is beveled to assist in piercing tissue of the eye.

Additionally, in the pre-deployment configuration, a portion of theshaft 104 extends beyond the sleeve 105 (FIG. 6C). The deploymentmechanism is configured such that member 114 a abuts a proximal end ofthe first portion 113 a 1 of channel 113 a, and member 114 b abut aproximal end of the first portion 113 b 1 of channel 113 b (FIG. 6B). Inthis configuration, the ready indicator 111 is visible through slot 106of the housing 101, providing feedback to an operator that thedeployment mechanism is in a configuration for deployment of anintraocular shunt from the deployment device 100 (FIG. 6A). In thisconfiguration, the device 100 is ready for insertion into an eye(insertion configuration or pre-deployment configuration). Methods forinserting and implanting shunts are discussed in further detail below.

Once the device has been inserted into the eye and advanced to alocation to where the shunt will be deployed, the shunt 115 may bedeployed from the device 100. The deployment mechanism 103 is atwo-stage system. The first stage is engagement of the pusher component118 and the second stage is retraction of the proximal portion 109 towithin the distal portion 110 of the deployment mechanism 103. Rotationof the rotating portion 110 a of the distal portion 110 of thedeployment mechanism 103 sequentially engages the pusher component andthen the retraction component.

In the first stage of shunt deployment, the pusher component is engagedand the pusher partially deploys the shunt from the deployment device.During the first stage, rotating portion 110 a of the distal portion 110of the deployment mechanism 103 is rotated, resulting in movement ofmembers 114 a and 114 b along first portions 113 a 1 and 113 b 1 inchannels 113 a and 113 b. Since the first portion 113 a 1 of channel 113a is straight and runs perpendicular to the length of the rotatingportion 110 a, rotation of rotating portion 110 a does not cause axialmovement of member 114 a. Without axial movement of member 114 a, thereis no retraction of the proximal portion 109 to within the distalportion 110 of the deployment mechanism 103. Since the first portion 113b 1 of channel 113 b runs diagonally along the length of the rotatingportion 110 a, upwardly toward a proximal end of the deploymentmechanism 103, rotation of rotating portion 110 a causes axial movementof member 114 b toward a proximal end of the device. Axial movement ofmember 114 b toward a proximal end of the device results in forwardadvancement of the pusher component 118 within the hollow shaft 104.Such movement of pusher component 118 results in partially deployment ofthe shunt 115 from the shaft 104.

FIGS. 7A-7C show schematics of the deployment mechanism at the end ofthe first stage of deployment of the shunt from the deployment device.As is shown FIG. 7A, members 114 a and 114 b have finished traversingalong first portions 113 a 1 and 113 b 1 of channels 113 a and 113 b.Additionally, pusher component 118 has advanced within hollow shaft 104(FIG. 7B), and shunt 115 has been partially deployed from the hollowshaft 104 (FIG. 7C). As is shown in these figures, a portion of theshunt 115 extends beyond an end of the shaft 104.

In the second stage of shunt deployment, the retraction component isengaged and the proximal portion of the deployment mechanism isretracted to within the distal portion of the deployment mechanism,thereby completing deployment of the shunt from the deployment device.During the second stage, rotating portion 110 a of the distal portion110 of the deployment mechanism 103 is further rotated, resulting inmovement of members 114 a and 114 b along second portions 113 a 2 and113 b 2 in channels 113 a and 113 b. Since the second portion 113 b 2 ofchannel 113 b is straight and runs perpendicular to the length of therotating portion 110 a, rotation of rotating portion 110 a does notcause axial movement of member 114 b. Without axial movement of member114 b, there is no further advancement of pusher 118. Since the secondportion 113 a 2 of channel 113 a runs diagonally along the length of therotating portion 110 a, downwardly toward a distal end of the deploymentmechanism 103, rotation of rotating portion 110 a causes axial movementof member 114 a toward a distal end of the device. Axial movement ofmember 114 a toward a distal end of the device results in retraction ofthe proximal portion 109 to within the distal portion 110 of thedeployment mechanism 103. Retraction of the proximal portion 109,results in retraction of the hollow shaft 104. Since the shunt 115 abutsthe pusher component 118, the shunt remains stationary at the hollowshaft 104 retracts from around the shunt 115 (FIG. 8C). The shaft 104retracts almost completely to within the sleeve 105. During both stagesof the deployment process, the sleeve 105 remains stationary and in afixed position.

FIG. 8A shows a schematic of the device 100 after deployment of theshunt 115 from the device 100. FIG. 8B shows a schematic of thedeployment mechanism at the end of the second stage of deployment of theshunt from the deployment device. As is shown in FIG. 8B, members 114 aand 114 b have finished traversing along second portions 113 a 1 and 113b 1 of channels 113 a and 113 b. Additionally, proximal portion 109 hasretracted to within distal portion 110, thus resulting in retraction ofthe hollow shaft 104 to within the sleeve 105. FIG. 8D shows an enlargedview of the distal portion of the deployment device after deployment ofthe shunt. This figure shows that the hollow shaft 104 is not fullyretracted to within the sleeve 105 of the deployment device 100.However, in certain embodiments, the shaft 104 may completely retract towithin the sleeve 105.

Referring to FIG. 8A, in the post-deployment configuration, the deployedindicator 119 is visible through slot 106 of the housing 101, providingfeedback to the operator that the deployment mechanism has been fullyengaged and that the shunt 115 has been deployed from the deploymentdevice 100.

Any of a variety of methods known in the art may be used to insertdevices of the invention into an eye. In certain embodiments, devices ofthe invention may be inserted into the eye using an ab externo approach(entering through the conjunctiva) or an ab interno approach (enteringthrough the cornea).

In certain embodiments, devices of the invention are inserted into theeye using an ab interno approach. Ab interno approaches for implantingan intraocular shunt are shown for example in Yu et al. (U.S. Pat. No.6,544,249 and U.S. Patent Application No. 2008/0108933) and Prywes (U.S.Pat. No. 6,007,511), the content of each of which is incorporated byreference herein in its entirety.

Devices of the invention may be inserted into the eye to deploy shuntsthat create fluid drainage passageways from the anterior chamber of theeye to various drainage structures of the eye. Exemplary drainagestructures include Schlemm's canal, the subconjunctival space, theepiscleral vein, the suprachoroidal space, or the intra-Tenon's space.In certain embodiments, fluid is drained to the subarachnoid space.

In particular embodiments, devices of the invention are inserted intothe eye to deploy shunts that create fluid drainage passageways from theanterior chamber to the intra-Tenon's space. Within an eye, there is amembrane known as the conjunctiva, and the region below the conjunctivais known as the subconjunctival space. Within the subconjunctival spaceis a membrane known as Tenon's capsule. Below Tenon's capsule there areTenon's adhesions that connect the Tenon's capsule to the sclera. Thespace between Tenon's capsule and the sclera where the Tenon's adhesionsconnect the Tenon's capsule to the sclera is known as the intra-Tenon'sspace.

FIGS. 9A-9B show an intraocular shunt placed into the eye using devicesof the invention such that the shunt forms a passage for fluid drainagefrom the anterior chamber to the intra-Tenon's space. To place the shuntwithin the eye, a surgical intervention to implant the shunt isperformed that involves inserting into the eye 202 a deployment device200 that holds an intraocular shunt 201, and deploying at least aportion of the shunt 201 within intra-Tenon's space 208, within thesubconjunctival space 209 and below the conjunctiva 210. In certainembodiments, a hollow shaft 206 of a deployment device 200 holding theshunt 201 enters the eye 202 through the cornea 203 (ab internoapproach). The shaft 206 is advanced across the anterior chamber 204 (asdepicted by the broken line) in what is referred to as a transpupilimplant insertion. The shaft 206 is advanced through the sclera 205until a distal portion of the shaft 206 is in proximity to Tenon'scapsule 207.

Once a distal portion of the hollow shaft 206 is within theintra-Tenon's space 208, the shunt 201 is then deployed from the shaft206 of the deployment device 200, producing a conduit between theanterior chamber 204 and the intra-Tenon's space 208 to allow aqueoushumor to drain from the anterior chamber 204 (see FIGS. 9A and 9B).

COMBINATIONS OF EMBODIMENTS

As will be appreciated by one skilled in the art, individual features ofthe invention may be used separately or in any combination.Particularly, it is contemplated that one or more features of theindividually described above embodiments may be combined into a singleshunt.

INCORPORATION BY REFERENCE

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

EQUIVALENTS

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The foregoingembodiments are therefore to be considered in all respects illustrativerather than limiting on the invention described herein.

What is claimed is:
 1. A method for deploying an intraocular shuntwithin an eye, the method comprising: inserting a device into an eye,the device comprising a hollow shaft extending within a sleeve, theshaft holding an intraocular shunt; advancing the shaft through the eyeuntil a distal edge of the sleeve contacts anterior chamber angle tissueto provide resistance against further advancement of the device; andadvancing the shunt from the device and into the eye to form a flow pathfrom an anterior chamber of the eye to an area of lower pressure.
 2. Themethod of claim 1, wherein the advancing comprises advancing the devicethrough the eye until the distal edge of the sleeve contacts sclera. 3.The method of claim 1, wherein the advancing comprises advancing theshaft until the distal edge of the sleeve presses against the anteriorchamber angle tissue.
 4. The method of claim 1, wherein the insertingstep comprises introducing the device into the eye through a cornea ofthe eye.
 5. The method according to claim 1, wherein the area of lowerpressure is selected from the group consisting of: intra-Tenon's space,the subconjunctival space, the episcleral vein, the suprachoroidalspace, and Schlemm's canal.
 6. The method according to claim 1, whereinthe device comprises a deployment mechanism at least partially disposedwithin a housing thereof, and wherein rotation of the deploymentmechanism results in axial movement of the shaft relative to the shuntto advance the shunt relative to the shaft, the method furthercomprising rotating the deployment mechanism to advance the shunt fromthe device and into the eye.
 7. The method according to claim 6, whereinthe rotating causes proximal axial movement of the shaft into thesleeve.
 8. A method for deploying an intraocular shunt within an eye,the method comprising: inserting a device into an eye, the devicecomprising a hollow shaft extending within a sleeve, the shaft holdingan intraocular shunt; positioning the device such that a distal edge ofthe sleeve contacts anterior chamber angle tissue; and with the sleevedistal edge contacting the anterior chamber angle tissue, advancing theshunt from the device and into the eye.
 9. The method according to claim8, wherein the positioning comprises advancing the shaft through thetissue.
 10. The method according to claim 9, wherein the positioningcomprises maintaining a position of the device relative to the anteriorchamber upon contacting the anterior chamber angle tissue.
 11. Themethod according to claim 8, wherein the advancing comprises forming aflow path from an anterior chamber of the eye to an area of lowerpressure.
 12. The method according to claim 11, wherein the area oflower pressure is selected from the group consisting of: intra-Tenon'sspace, the subconjunctival space, the episcleral vein, thesuprachoroidal space, and Schlemm's canal.
 13. The method according toclaim 8, wherein the inserting step comprises introducing the deviceinto the eye through a cornea of the eye.
 14. A method for deploying anintraocular shunt within an eye, the method comprising: providing adevice comprising a sleeve and a hollow shaft extending within thesleeve and configured to hold an intraocular shunt; inserting the deviceinto an eye; advancing the device into an anterior chamber of the eyesuch that shaft pierces the eye tissue; and while maintaining a distaledge of the sleeve at a substantially fixed position relative to thetissue, advancing the shunt from the device.
 15. The method according toclaim 14, wherein the advancing the device comprises advancing the shaftinto the eye tissue until the sleeve distal edge is positioned at adesired location, spaced apart from the tissue, such that a proximal endof the shunt is positioned at the desired location after the shunt isadvanced from the device.
 16. The method according to claim 14, whereinthe advancing the device comprises advancing the device until the sleevedistal edge contacts the tissue to provide resistance against furtheradvancement of the device.
 17. The method according to claim 14, whereinthe advancing the device comprises forming a flow path from an anteriorchamber of the eye to an area of lower pressure selected from the groupconsisting of: intra-Tenon's space, the subconjunctival space, theepiscleral vein, the suprachoroidal space, and Schlemm's canal.
 18. Themethod according to claim 14, wherein the advancing the shunt isperformed while the sleeve distal edge is spaced apart from the tissueat the fixed position.
 19. The method according to claim 18, wherein theadvancing the shunt comprises advancing a plunger within the shaft tourge the shunt into the tissue.
 20. The method according to claim 14,wherein the inserting step comprises introducing the device into the eyethrough a cornea of the eye.